DETAILED ACTION
Applicant’s arguments, filed 28 January 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-16, 18-20 and 24-26 are pending; claims 1-12 and 25-26 are examined; claims 13-16, 18-20 and 24 are withdrawn.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Garti et al. (US 2021/0137829 A1, 05/13/2021) (hereinafter Garti).
Garti discloses topical formulations for transdermal delivery of an active agent ([0022], [0037]) comprising about 1-6 wt. % ([0092]) of an active agent such as diclofenac ([0122]); about 0.4-2 wt. % ([0080]) of a phospholipid such as phosphatidyl choline ([0078]); about 2-10 wt. % ([0082]) of a penetration promotor such as urea ([0084]); a solvent such as ethanol ([0067]); and pH adjusting agents and buffers such as citric acid ([0103]).
Together these would provide compositions as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the recited weight ratio of the non-steroid anti-inflammatory drug (NSAID) and the at least one phospholipid, it would have been obvious to one of ordinary skill in the art to have selected an amount of the NSAID from the disclosed range of about 1-6 wt. % and an amount of phospholipid from the disclosed range of about 0.4-2 wt. %, such that the amounts selected would have equated to a weight ratio that overlaps with the instantly claimed weight ratio, thus making the claimed weight ratio obvious. See MPEP 2144.05(I). Moreover, in any case, the selection of appropriate weight ratios from disclosed ranges would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ratio ranges to arrive at the claimed weight ratios. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claims 2, 4, 6, and 12 reciting amounts of the at least one active agent, at least one phospholipid, and urea, the claimed ranges (i.e. about 0.1 wt. % to about 10.0 wt. %; about 0.1 wt. % to about 20.0 wt. %; and about 5.0 wt. % to about 50.0 wt. %, respectively) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art (i.e. about 1-6 wt. %; about 0.4-2.0 wt. %; and about 2-10 wt. %, respectively). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 25, Garti further discloses wherein the phospholipid may include soy lecithin ([0078]).
Response to Arguments
Applicant mainly asserts the instantly claimed ratio of NSAID : phospholipid is not taught or suggested in Garti, and such parameter is critical to both phase stability and high active loading. Applicant further states Example 2 and Table 2 demonstrate a translucent or transparent product was formed when the ratio of diclofenac sodium to SPC varied within the instantly claimed ratio, but precipitation occurred when the ratio of diclofenac sodium to SPC was increased to 9:1. Example 3 demonstrated NSAID solubility enhancement when both phospholipid and urea are present, in particular, diclofenac formulations containing urea with an NSAID : phospholipid ratio within the claimed range were stable, whereas a comparative formulation without urea showed phase separation. Applicant further points to Table 1, Example 4, and Table 4 and asserts stable formulations were achieved across 3 structurally diverse NSAID classes. Thus, Applicant asserts the claimed range of NSAID : phospholipid ratios is not a matter of routine optimization but a previously unrecognized boundary critical for formulation stability and solubility with NSAID cross-class applicability. Finally, Applicant further asserts Garti only teaches the use of urea as a penetrating promoter to increase penetration of its formulation into the skin, but does not disclose or suggest the solubility enhancement achieved with the claimed formulation when the combination of NSAID, phospholipid, and urea is present simultaneously within the critical NSAID : phospholipid range.
Although the Examiner appreciates Applicant’s remarks, the Examiner does not find Applicant’s assertions to be persuasive.
Based on the broadest reasonable interpretation consistent with the Specification, Garti discloses NSAID, phospholipid, and urea in amounts that overlap with the instantly claimed ranges, specifically about 1-6 wt. % of NSAID; about 0.4-2 wt. % of phospholipid. Accordingly, it would have been obvious to one of ordinary skill in the art to have selected a disclosed amount of the NSAID and the phospholipid, such that the amounts selected would have equated to a weight ratio that overlaps with the instantly claimed weight ratio, thus making the claimed weight ratio obvious. See MPEP 2144.05(I).
Moreover, Garti discloses in para. [0104] wherein the formulations are substantially transparent and have high stability, lacking any observable clouding or areas of phase separation or bioactive precipitation. Given such explicit disclosure from Garti, it is unclear to the Examiner how the composition of amended instant claim 1, reciting a topical composition comprising: a presence of at least one active comprising a NSAID; a presence of at least one phospholipid; and a presence of urea, having a NSAID : phospholipid weight ratio of between 2:8 and 8:2, distinguishes itself over the disclosure of Garti.
Regarding Applicant’s assertion about Garti using urea for a different purpose, the Examiner notes that rationale different’ from Applicant’s is permissible. It is not necessary for the prior art to suggest the combination to achieve the same advantage or result discovered by Applicant. See MPEP 2144(IV). Thus, it is not necessary for Garti to disclose using urea for the same reason as Applicant, which is for solubility enhancement. As such, Applicant’s assertions are unpersuasive.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tatapudy et al. (US 2007/0053968 A1, 03/08/2007), directed to transdermal drug delivery of pharmacologically active agents, comprising solvents, emulsifying agents, and permeation enhancing agents.
Piazza et al. (US 5,340,568 A, 08/23/1994), directed to topical application of anti-inflammatory agents, penetration enhancing agents, and a phospholipid.
Alhakamy et al. (US 2022/0023244 A1, 01/27/2022), directed to compositions for topical application comprising a non-steroidal anti-inflammatory drugs, dispersing agents, buffering agents, and humectants.
Register (US 2021/0220259 A1, 07/22/2021), directed to topical compositions comprising rofecoxib, humectant, and moisturizing agents.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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